The European Commission is playing its cards close to its chest but signaling a clear intention: to maintain and renew its delegated authority in the realm of cross-border healthcare. By aiming for an automatic extension of these powers, it stakes a claim for ongoing influence over the exclusion of certain medicinal products and the governance of European Reference Networks (ERNs). The main players affected here include healthcare providers, pharmaceutical manufacturers, EU national health authorities, and patients seeking care across borders — all poised for varying reactions given the Commission’s push to keep flexibility in health policy.
This development is laid out in the report COM(2025)757, published on December 12, 2025, by the Directorate-General for Health and Food Safety (SANTE). The report responds to Article 17(1) of Directive 2011/24/EU and updates the European Parliament and Council on the Commission’s exercise of delegated powers related to patients’ rights in cross-border healthcare.
Classified as a monitoring and renewal report rather than new legislation, the document contains no new policy proposals or numeric targets but recommends an automatic five-year extension of existing delegated powers. No delegated acts have been exercised since the last report in 2018, suggesting regulatory stability, but the Commission stresses the importance of retaining these powers for future public health safeguards and maintaining ERN standards.
The policy orientation underscores preserving EU-level regulatory flexibility over increasing or decreasing powers, prioritizing adaptability in health regulation versus a potentially more static national control approach. It reiterates the ongoing tension between ensuring patient safety and the sovereignty of member states in healthcare provision, without altering the established regulatory framework.
Stakeholders will see mixed impacts: national health authorities retain their core responsibilities but must coordinate with an empowered Commission overseeing prescription exclusions and ERN criteria — a moderate operational burden. Pharmaceutical companies face limited direct changes now but could encounter regulatory shifts if future delegated acts are triggered. Cross-border patients and healthcare providers are positioned to benefit from stable frameworks supporting access and network quality, though without immediate enhancements. EU taxpayers and civil society will observe a cautious regulatory stance focused on preparedness rather than expansion.
Institutionally, this report signals a continuation of an ongoing process, where the European Parliament and Council are expected to decide on renewing the Commission’s delegated powers. It neither initiates nor concludes the policy cycle but sets the stage for future oversight and responsiveness to public health dynamics in EU cross-border healthcare.